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临床试验/CTRI/2024/08/072327
CTRI/2024/08/072327尚未招募3 期

Effect of Bilateral Intranasal Transmucosal Sphenopalatine Ganglion Block for Postoperative Analgesia in Funtional Endoscopic Sinus Surgery:A Randomised Placebo Control Study.

ABVIMS and DR RML Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年8月22日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
52
试验地点
1
主要终点
Time to request first rescue analgesic in postoperative period according to VAS score

研究概览

简要总结

This is Randomised Placebo Control study to determine the effect of bilateral intranasal transmucosal sphenopalatine ganglion block for post operative analgesia in functional endoscopic sinus surgery.It will be conducted in the Department of Anaesthesiology,ABVIMS AND DR RML HOSPITAL,New Delhi-110001.The study will include adult patients of 18 to 65years of age (26 in each group) undergoing functional endoscopic sinus surgery.The primary outcome is to note the time taken to request first rescue analgesic in postoperative period.The secondary outcome is to determine the total rescue analgesic consumption in first 24 hours,To assess hemodynamic parameters during intraoperative period,To note total consumption of Fentanyl in intraoperative period,To note the total consumption of antihypertensives in intraoperative period,To document any complications of the block.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Adults aged 18 to 65years posted for elective functional endoscopic sinus surgery
  • ASA CLASS 1 and 2.

排除标准

  • Patients with nasal deformities
  • Patients allergic to local anaesthetics
  • Patients with bleeding disorders
  • Patients with pregnancy.

结局指标

主要结局

Time to request first rescue analgesic in postoperative period according to VAS score

时间窗: Post operative analgesia will be assessed using VAS score and if VAS score is greater than 3 then rescue analgesic in the form of Inj Tramadol 50mg IV will be given for next 24 hours

次要结局

  • To determine total rescue analgesic consumption(If VAS score is greater than 3 then rescue analgesic in the form of Inj Tramadol 50mg IV will be given for 24 hours)
  • To assess hemodynamic parameters which includes Blood Pressure(Heart Rate)
  • To note the total consumption of Fentanyl in intraoperative period(If heart rate raises greater than 20 percent of baseline then bolus dose of Inj Fentanyl 0.5mcg per kg will be given)
  • To note total consumption of antihypertensives in intraoperative period(Inj Nitroglycerin & Inj Metoprolol will be used in this study)
  • To document any complications of the block in intraoperative & postoperative period(Any complications will be noted)

研究者

发起方
ABVIMS and DR RML Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kuna Kripa Rani

ABVIMS AND DR RML HOSPITAL NEW DELHI

研究点 (1)

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